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Share Name | Share Symbol | Market | Type |
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Tenax Therapeutics Inc | NASDAQ:TENX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.01 | 0.26% | 3.80 | 3.64 | 8.30 | 3.86 | 3.78 | 3.83 | 13,798 | 05:00:02 |
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SUMMARY
This summary is not complete and does not contain all of the
information you should consider before investing in the securities
offered by this prospectus. You should read this summary together
with the entire prospectus, including our financial statements, the
notes to those financial statements, and the other documents
identified under the headings “Where You Can Find More
Information” and “Incorporation of Certain Information
by Reference” in this prospectus before making an investment
decision. See the Risk Factors section of this prospectus on page 7
for a discussion of the risks involved in investing in our
securities.
Overview
Tenax
Therapeutics is a specialty pharmaceutical company focused on
identifying, developing and commercializing products that
address cardiovascular and pulmonary diseases of high unmet medical
need. On November 13, 2013, through our wholly owned subsidiary,
Life Newco, Inc., or Life Newco, we acquired a license granting
Life Newco an exclusive, sublicenseable right to develop and
commercialize pharmaceutical products containing levosimendan, 2.5
mg/ml concentrate for solution for infusion / 5ml vial in the
United States and Canada.
Our
principal executive offices are located at ONE Copley Parkway,
Suite 490, Morrisville, North Carolina 27560, and our telephone
number is (919) 855-2100. Our Internet address is
http://www.tenaxthera.com. The information on our website is not
incorporated by reference into this prospectus, and you should not
consider it part of this prospectus.
Tenax
Therapeutics was originally formed as a New Jersey corporation in
1967 under the name Rudmer, David & Associates, Inc., and
subsequently changed its name to Synthetic Blood International,
Inc. Effective June 30, 2008, we changed the domiciliary state of
the corporation to Delaware and changed the company name to Oxygen
Biotherapeutics, Inc. On September 19, 2014, we changed the company
name to Tenax Therapeutics, Inc.
Business Strategy
Our
principal business objective is to identify, develop, and
commercialize novel therapeutic products for disease indications
that represent significant areas of clinical need and commercial
opportunity. The key elements of our business strategy are outlined
below.
Efficiently conduct clinical
development to establish clinical proof of concept with our current
product candidate. Levosimendan represents novel therapeutic
modalities for the treatment of pulmonary hypertension and
other cardiovascular and pulmonary diseases of high unmet
medical need. We are conducting clinical development with the
intent to establish proof of concept in several important disease
areas where these therapeutics would be expected to have benefit.
Our focus is on conducting well-designed studies to establish a
robust foundation for subsequent development, partnership and
expansion into complementary areas.
Efficiently explore new high
potential therapeutic applications, leveraging third-party research
collaborations and our results from related
areas. Our product candidate
has shown promise in multiple disease areas. We are committed to
exploring potential clinical indications where our therapies may
achieve best-in-class profile, and where we can address significant
unmet medical needs. In order to achieve this goal, we have
established collaborative research relationships with investigators
from research and clinical institutions and our strategic partners.
These collaborative relationships have enabled us to cost
effectively explore where our product candidates may have
therapeutic relevance, and how it may be utilized to advance
treatment over current clinical care. Additionally, we believe we
will be able to leverage clinical safety data and preclinical
results from some programs to support accelerated clinical
development efforts in other areas, saving substantial development
time and resources compared to traditional drug
development.
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Continue to expand our
intellectual property portfolio. Our intellectual property is important to our
business and we take significant steps to protect its value. We
have ongoing research and development efforts, both through
internal activities and through collaborative research activities
with others, which aim to develop new intellectual property and
enable us to file patent applications that cover new applications
of our existing technologies or product
candidates.
Enter into licensing or
product co-development arrangements. In addition to our internal development efforts,
an important part of our product development strategy is to work
with collaborators and partners to accelerate product development,
reduce our development costs, and broaden our commercialization
capabilities. We believe this strategy will help us to develop a
portfolio of high-quality product development opportunities,
enhance our clinical development and commercialization
capabilities, and increase our ability to generate value from our
proprietary technologies.
Our Current Programs
Levosimendan Background
Levosimendan was discovered and developed by Orion
Corporation, a Finnish company, or Orion. Levosimendan is
a calcium sensitizer/K-ATP
activator developed for
intravenous use in hospitalized patients with acutely decompensated
heart failure. It is currently approved in over 60 countries for
this indication and not available in the United States or Canada.
It is estimated that to date over 1.5 million patients have been
treated worldwide with levosimendan.
Levosimendan is a novel, first in
class calcium sensitizer/K-ATP
activator. The therapeutic
effects of levosimendan are mediated through:
● Increased
cardiac contractility by calcium sensitization of troponin C,
resulting in a positive inotropic effect which is not associated
with substantial increases in oxygen demand.
● Opening
of potassium channels in the vasculature smooth muscle, resulting
in a vasodilatory effect on all vascular beds.
● Opening
of mitochondrial potassium channels in cardiomyocytes, resulting in
a cardioprotective effect.
This triple mechanism of action helps to preserve heart function
during cardiac surgery. Several studies have demonstrated that
levosimendan protects the heart and improves tissue perfusion while
minimizing tissue damage during cardiac surgery.
In
2013, we acquired certain assets of Phyxius Pharma, Inc., or
Phyxius, including its North American rights to develop and
commercialize levosimendan for any indication in the United States
and Canada. In the countries where levosimendan is marketed,
levosimendan is indicated for the short-term treatment of acutely
decompensated severe chronic heart failure in situations where
conventional therapy is not sufficient, and in cases where
inotropic support is considered appropriate. In acute
decompensated heart failure patients, levosimendan has been shown
to significantly improve patients’ symptoms as well as acute
hemodynamic measurements such as increased cardiac output, reduced
preload and reduced afterload.
The
European Society of Cardiology, or the ESC, recommends levosimendan
as a preferable agent over dobutamine to reverse the effect of beta
blockade if it is thought to be contributing to hypotension. The
ESC guidelines also state that levosimendan is not appropriate for
patients with systolic blood pressure less than 85mmHg or in
patients in cardiogenic shock unless it is used in combination with
other inotropes or vasopressors. Other unique properties of
levosimendan include sustained efficacy through the formation of a
long acting metabolite, lack of impairment of diastolic function,
and evidence of better compatibility with beta blockers than
dobutamine.
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Levosimendan Development for Pulmonary Hypertension
Patients
We
are currently conducting a Phase 2 clinical trial of levosimendan
in North America for the treatment of patients with pulmonary
hypertension associated with heart failure with preserved ejection
fraction, or PH-HFpEF. PH-HFpEF is defined hemodynamically by
a pulmonary artery pressure, or mPAP, ≥25 mmHg, a pulmonary
capillary wedge pressure, or PCWP, >15 mmHg, and a diastolic
pressure gradient, or diastolic PAP – PCWP, >7mmHg.
Pulmonary hypertension in these patients initially develops from a
passive backward transmission of elevated filling pressures from
left-sided heart failure. These mechanical components of pulmonary
venous congestion may trigger pulmonary vasoconstriction, decreased
nitric oxide availability, increased endothelin expression,
desensitization to natriuretic peptide induced vasodilation, and
vascular remodeling. Finally, these changes often lead to
advanced pulmonary vascular disease, increased right ventricle, or
RV, afterload, and RV failure.
PH-HFpEF
is a common form of pulmonary hypertension with an estimated US
prevalence exceeding 1.5 million patients. Currently, no
pharmacologic therapies are approved for treatment of
PH-HFpEF. Despite the fact that many therapies have been
studied in PH-HFpEF patients, including therapies approved to treat
pulmonary arterial hypertension patients, no therapies have been
shown to be effective in treating PH-HFpEF patients.
Published
pre-clinical and clinical studies indicate that levosimendan may
provide important benefits to patients with pulmonary hypertension.
Data from these published trials indicate that levosimendan may
reduce pulmonary vascular resistance and improve important
cardiovascular hemodynamics such as reduced pulmonary capillary
wedge pressure in patients with pulmonary hypertension. In
addition, several published studies provide evidence that
levosimendan may improve right ventricular dysfunction which is a
common comorbidity in patients with pulmonary hypertension. While
none of these studies have focused specifically on PH-HFpEF
patients, the general hemodynamic improvements in these published
studies of various types of pulmonary hypertension provide an
indication that levosimendan may be beneficial in PH-HFpEF
patients.
In March 2018, we met with the United States Food
and Drug Administration, or FDA, to discuss development of
levosimendan in PH-HFpEF patients. The FDA agreed with our planned
Phase 2 design, patient entry criteria, and endpoints. It was
agreed the study could be conducted under the existing
investigational new drug application with no additional nonclinical
studies required to support full development. The FDA recognized
there were no approved drug therapies to treat PH-HFpEF patients
and acknowledged this provided an opportunity for a limited Phase 3
clinical program. This topic will be discussed further at the
End-of-Phase 2 Meeting following completion of the Phase 2 study in
PH-HFpEF patients, which is known as the HELP Study –
Hemodynamic
Evaluation
of Levosimendan in PH-HFpEF. We initiated the first of our expected
10-12 HELP Study clinical sites in November 2018 and the first of
36 patients was enrolled in the HELP Study in March 2019.
Enrollment in the HELP Study was completed in March 2020. The
primary endpoint of the HELP Study is based on change in PCWP vs
baseline compared to placebo. The HELP Study utilizes a
double-blind randomized design following five weekly infusions of
levosimendan.
On
June 2, 2020, we announced preliminary, top-line data from the
study. The primary efficacy analysis, pulmonary capillary wedge
pressure (PCWP) during exercise did not demonstrate a statistically
significant reduction from baseline. Levosimendan did demonstrate a
statistically significant reduction in PCWP compared to baseline
(p=<0.0017) and placebo (p=<0.0475) when the measurements at
rest, with legs up and on exercise were combined. Levosimendan also
demonstrated a statistically significant improvement in 6-minute
walk distance (6MWD) as compared to placebo
(p=0.0329).
Hemodynamic Results
Hemodynamic
measurements were made at rest (supine), after leg raise on a
supine bicycle (a test of rapid increase in ventricular filling)
and during exercise (25 watts for 3 minutes or until the patient
tired). Levosimendan demonstrated a statistically significant
reduction in PCWP compared to baseline (p=<0.0017) and placebo
(p=<0.0475) when the measurements at rest, with legs up and on
exercise were combined. While there was no significant change in
PCWP during exercise, patients receiving levosimendan had
reductions from baseline at Week 6 in PCWP, pulmonary artery
pressure (PAP), and right atrial pressure (RAP) that were
significant when patients were “at rest” and/or with
their “legs raised” (p<0.05).
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Clinical Results (6 Minute Walk Distance)
The
clinical efficacy was confirmed by a statistically significant
improvement in 6-minute walk distance of 29 meters. (p=0.0329). The
6-minute walk distance was a secondary endpoint in the trial and is
a validated and accepted endpoint used in many pulmonary
hypertension registration trials. Levosimendan was given in
once-weekly home infusions for 6 weeks.
Safety
The
incidence of AEs or SAEs between the control and treated groups
were similar. In addition, there were no arrhythmias observed,
atrial or ventricular, when comparing baseline electrocardiographic
monitoring with 72-hour monitoring after 5 weeks of
treatment.
We
plan to present the full study results at future medical meetings
and will submit a full manuscript of the trial results to a
peer-reviewed journal.
Intellectual Property
We
rely on a combination of patent applications, patents, trade
secrets, proprietary know-how, trademarks, and contractual
provisions to protect our proprietary rights. We believe that to
have a competitive advantage, we must develop and maintain the
proprietary aspects of our technologies. Currently, we require our
officers, employees, consultants, contractors, manufacturers,
outside scientific collaborators and sponsored researchers, and
other advisors to execute confidentiality agreements in connection
with their employment, consulting, or advisory relationships with
us, where appropriate. We also require our employees, consultants,
and advisors who we expect to work on our products to agree to
disclose and assign to us all inventions conceived during the
workday, developed using our property, or which relate to our
business.
To
date, we own or in-license the rights to six U.S. and foreign
patents. In addition, we have one U.S. patent application pending
related to a product candidate and proprietary process, method and
technology. Our issued and in-licensed patents, as well as our
pending patents, expire between 2023 and 2038.
We
have:
● one
U.S. patent (8,404,752), one Australian Patent (209,271,530) and
one European patent (EPO9798325.8) held jointly with Virginia
Commonwealth University Intellectual Property Foundation for the
treatment of traumatic brain injury;
● one
Israeli patent (215516) and numerous patent applications, including
one U.S. patent application, for the formulation of perfluorocarbon
emulsion with an average remaining life of approximately 13 years;
and
● two
U.S. patents (6,730,673 and 6,943,164) for the intravenous
formulation of levosimendan as in-licensed patent rights for our
development and commercialization of levosimendan in the United
States and Canada.
Our
patent and patent applications include claims covering all various
uses of levosimendan, our lead product candidate currently under
development, as well as the manufacturing and use of our
perfluorocarbon emulsion formulation. We have filed a patent
application for a subcutaneous formulation of levosimendan that we
have developed in collaboration with a formulation development
partner. In addition, we have filed a provisional patent
application for the use of levosimendan in the treatment of
PH-HFpEF patients based on several discoveries that have emerged
from the HELP Study. The HELP Study is the first and only trial to
evaluate the use of levosimendan to treat PH-HFpEF patients, a
patient population where all previously tested therapies have
failed to show effectiveness.
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The
U.S. trademark registration for Simdax® is owned by Orion
and is licensed to us for sales and marketing purposes for any
pharmaceutical products containing levosimendan that are
commercialized in the United States and Canada.
Recent Developments
On July
6, 2020, we entered into a Securities Purchase Agreement for Class
C and Class D Units, or the RDO Purchase Agreement, with an
institutional investor, or the Investor, and a Securities Purchase
Agreement for Class E and Class F Units, or the PIPE Purchase
Agreement, and, together with the RDO Purchase Agreement, the
Purchase Agreements, pursuant to which we agreed to issue in a
registered direct offering 2,523,611 shares of our common stock,
$0.0001 par value per share, at a purchase price of $1.02780 per
share and pre-funded warrants, or the Registered Pre-Funded
Warrants, to purchase up to 652,313 shares of common stock at a
purchase price of $1.02770 per Registered Pre-Funded Warrant, and
issue in a concurrent private placement unregistered pre-funded
warrants, or the Unregistered Pre-Funded Warrants, to purchase up
to 4,607,692 shares of common stock at the same purchase price as
the Registered Pre-Funded Warrants, and unregistered common stock
warrants, or the Unregistered Warrants, to purchase up to 7,783,616
shares of common stock (such registered direct offering and private
placement are collectively referred to as the Offerings). The
aggregate gross proceeds to us of the Offerings was approximately
$8.0 million.
The
Registered Pre-Funded Warrants and the Unregistered Pre-Funded
Warrants have an exercise price of $0.0001 per share of common
stock, are immediately exercisable, may be exercised at any time
until exercised in full and are subject to customary adjustments.
The Unregistered Warrants have an exercise price of $0.903 per
share of common stock, are immediately exercisable, will expire
five and one-half years from the date of issuance and are subject
to customary adjustments.
The
Registered Pre-Funded Warrants, the Unregistered Pre-Funded
Warrants and Unregistered Warrants may not be exercised if the
aggregate number of shares of our common stock beneficially owned
by the holder (together with its affiliates) would exceed 19.99% of
our outstanding common stock immediately after exercise. However,
the holder may increase or decrease such percentage, provided that
in no event such percentage exceeds 19.99%, upon at least 61
days’ prior notice from the holder to us.
We
intend to use the net proceeds from the Offerings to further our
clinical trials of levosimendan, for research and development and
for general corporate purposes, including working capital and
potential acquisitions.
Also
on July 6, 2020 and in connection with the private placement, we
entered into a registration rights agreement, or the Registration
Rights Agreement, with the Investor, pursuant to which we
agreed to register for resale the shares of our common stock
issuable upon exercise of the
Unregistered Pre-Funded Warrants and the Unregistered
Warrants (collectively referred to as the Unregistered Warrant
Shares). Under the Registration Rights Agreement, we agreed to file
a registration statement covering the resale by the Investor of the
Unregistered Warrant Shares within 60 days following the date of
the Registration Rights Agreement.
Under certain
circumstances, including, but not limited to, (i) if the
registration statement is not filed within the time period
specified above or (ii) if the registration statement has
not been declared effective (A) by the 120th day
after the date of the Registration Rights Agreement (or, in the
event of a “full review” by the SEC, the
150th day
after the date of the Registration Rights Agreement) or
(B) within five trading days following the date we are
notified by the SEC that the registration statement will not be
reviewed or is no longer subject to further review and comments
then we have agreed to pay the Investor, as partial liquidated
damages, an amount equal to 1.0% of the Investor’s aggregate
subscription amount paid pursuant to the PIPE Purchase
Agreement.
Pursuant to the terms of the PIPE Purchase Agreement, we agreed to
appoint to our Board of Directors two directors designated in
writing by a majority in interest of the purchasers named therein,
or the Designor, following the closing of the Offerings. In the
event the Designor beneficially holds less than 19.90% but more
than 9.99% of our issued and outstanding common stock, then the
Designor shall have the right to designate only one director. On
July 20, 2020, Steven J. Boyd and Keith Maher, MD were appointed to
our Board of Directors.
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The Offering
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Common Stock Offered by Selling
Stockholders:
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14,958,874 shares
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Use of Proceeds:
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Tenax Therapeutics will not receive any proceeds from the sale of
our shares of common stock by the selling stockholders, although we
will receive proceeds from the exercise price of any warrants
exercised on a cash basis. We intend to use those proceeds, if any,
for working capital and general corporate purposes.
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Risk Factors:
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Investing in our common stock involves a high degree of risk. See
“Risk Factors” and other information contained in this
prospectus or otherwise incorporated by reference before deciding
to invest in shares of our common stock.
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Nasdaq Capital Market Symbol:
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Our common stock is listed on the Nasdaq Capital Market under the
symbol “TENX.”
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Name of Selling
Security Holder
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Number of Shares
of Common Stock Owned Prior to Offering
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Maximum Number
of Shares of Common Stock to be Sold Pursuant to this
Prospectus
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Number of Shares
of Common Stock Owned After Offering
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Percentage of
Common Stock Owned After Offering (1)
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Armistice Capital
Master Fund, Ltd. (2)
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21,569,005
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14,751,621
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6,817,384
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54%
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Ladenburg Thalmann
& Co., Inc.
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311,344
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207,253
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104,091
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